AN2 Therapeutics Receives U.S. FDA IND Clearance to Proceed with Planned Phase 2 Global Study of Oral Epetraborole in Polycythemia Vera
Key Highlights
- ➤FDA cleared epetraborole IND for Phase 2 polycythemia vera study
- ➤AN2 received regulatory clearance in Australia, India, and the U.S.
- ➤Global Phase 2 trial expected to begin in fourth quarter of 2026
- ➤Study will evaluate oral epetraborole in phlebotomy-dependent adults with polycythemia vera
Expert Statements
Cameron Trenor, Chief Medical Officer of AN2 Therapeutics
“We’re pleased to receive FDA IND clearance and the necessary authorizations globally to advance epetraborole into Phase 2 clinical development for polycythemia vera”
Cameron Trenor, Chief Medical Officer of AN2 Therapeutics
“Extensive preclinical and human data generated to date indicate that epetraborole has the potential to produce early, controlled, sustained and dose-dependent control of hematocrit, providing a strong rationale for clinical development in PV.”
Cameron Trenor, Chief Medical Officer of AN2 Therapeutics
“We anticipate initiating the Phase 2 trial in the fourth quarter of 2026.”
AN2 Therapeutics Receives U.S. FDA IND Clearance to Proceed with Planned Phase 2 Global Study of Oral Epetraborole in Polycythemia Vera
AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical stage biopharmaceutical company focused on the discovery and development of novel small molecule therapeutics derived from its boron chemistry platform, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for epetraborole in polycythemia vera (PV). The Company has now received regulatory clearance in all planned jurisdictions (Australia, India, and the U.S.) for the global study and expects to initiate the trial in the fourth quarter of 2026.
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